BACKGROUND
With rapid aging of the global population, the prevalence of mild cognitive impairment (MCI) and dementia is anticipated to surge worldwide. MCI serves as an intermediary stage between normal aging and dementia, necessitating more sensitive and effective screening tools for early identification and intervention. The BrainFx SCREEN™ is a novel digital tool designed to assess cognitive impairment. This study evaluates its efficacy as a screening tool for MCI in primary care settings, particularly in the context of an aging population and the growing integration of digital health solutions.
OBJECTIVE
The primary objective was to assess the validity, reliability, and applicability of the BrainFx SCREEN™ (the SCREEN) for MCI screening in a primary care context. We conducted an exploratory study comparing the SCREEN with an established screening tool, the Quick Mild Cognitive Impairment (Qmci) screen.
METHODS
A concurrent mixed methods, prospective study using a quasi-experimental design was conducted with 147 participants from five primary care family health teams (FHTs; defined by multidisciplinary practice and capitated funding) across southwestern Ontario, Canada. Participants included healthcare practitioners, patients, and FHT administrative executives. Patients 55 years and older with no history of MCI or diagnosis of dementia rostered in a participating FHT were eligible to participate. Participants were screened using both the SCREEN and Qmci. The study also incorporated the Geriatric Anxiety Scale-10 to assess general anxiety levels at each cognitive screening. The SCREEN’s scoring was compared against the Qmci and clinical judgement of healthcare professionals. Statistical analyses included sensitivity, specificity, internal consistency, and test-retest reliability assessments.
RESULTS
The study found that the SCREEN’s longer administration time and complex scoring algorithm, which is proprietary and unavailable for independent analysis, presented challenges. Its internal consistency, indicated by a Cronbach α=.63, was below the acceptable threshold. The test-retest reliability also showed limitations, with low intraclass correlation coefficient (ICC=0.54) and Kappa (k=0.15) values. Sensitivity and specificity were consistent (63.25% and 74.07%, respectively) between crosstabulation and discrepant analysis. Additionally, the study faced limitations due to its demographic skew (63% female, well-educated participants), the absence of a comprehensive “gold standard” for MCI diagnosis, and financial constraints limiting the inclusion of confirmatory neuropsychological testing.
CONCLUSIONS
The SCREEN, in its current form, does not meet the necessary criteria for an optimal MCI screening tool in primary care settings, primarily due to its longer administration time and lower reliability. As the number of digital health technologies increase and evolve, further testing and refinement of tools like the SCREEN are essential to ensure their efficacy and reliability in real-world clinical settings. The study advocates for continued research in this rapidly advancing field to better serve the aging population.
INTERNATIONAL REGISTERED REPORT
RR2-10.2196/25520